Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Reported: August 18, 2021 Initiated: June 4, 2021 #Z-2110-2021
Product Description
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Reason for Recall
System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 130135 units
- Distribution
- United States (including Puerto Rico), Canada, Bahamas, Bermuda, Guyana, and Trinidad and Tobago.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.. Recalled by Baxter Healthcare Corporation. Units affected: 130135 units.
Why was this product recalled? ▼
System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 18, 2021. Severity: Critical. Recall number: Z-2110-2021.
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